Saw-palmetto
pills may help--if they contain enough of the right stuff.

Saw palmetto, a traditional herbal remedy, began
its modern comeback in alternative-medicine circles in the early 1990s.
Word-of-mouth, marketing, and news of mostly European research showing
saw palmetto's benefits have made it one of the top ten best-selling herbal
remedies, with sales reaching $140 million in 1999. The remedy is used
to treat benign prostate problems, which affect 25 percent of men in their
50s and half of men over age 75. In a recent Consumer Reports survey,
more than a third of men with such prostate problems had tried saw palmetto.

Clinical
testing has now begun to catch up with saw palmetto's popularity. Results
show that early 20th-century physicians were onto something when they
used infusions and potions made from the fruit of the southeastern U.S.
palm plant for male genital and urinary problems.

Saw palmetto
has had an off-and-on relationship with official listings of plant and
pharmaceutical medicines by the United States Pharmacopeia (USP) and its
National Formulary (NF). The berry was included as a medicine for prostate
problems in the first half of the 20th century, dropped by the 1950s,
and reinstated just this year. An April 2000 USP monograph concluded that
clinical trials of saw palmetto "provide evidence of moderate scientific
quality that commercial extracts of saw palmetto ... are more effective
than a placebo in relieving lower-urinary-tract symptoms of BPH [benign
prostatic hyperplasia, or noncancerous enlargement of the gland]." The
report also found that the herbal remedy has no significant side effects
and only rarely causes mild stomach upset or diarrhea. (However, it noted
that drug interactions and medical contraindications have not yet been
studied adequately.)

Now that
the report has been published, manufacturers who voluntarily meet USP's
standards of potency and purity may place the USP's "NF" seal on their
labels.

But unlike
modern pharmaceuticals, made with chemicals in a lab, plant-based medicines
are notoriously difficult to standardize. Individual plants can vary greatly
in their content of key active chemicals. And consumers have virtually
no protection against inaccurate labeling or substandard preparation,
because of a lack of meaningful government regulation of herbal products.

For that
reason, Consumers Union is expanding its herbal-testing program. Over
the next few years, working with outside labs that specialize in testing
herbal products, we will test representative brands of herbal remedies
that are performing well in clinical trials. Our ingredient testing will
follow our usual standards, which include anonymous shopping at a variety
of retail outlets and, for many products, the testing of several samples
of each brand, obtained from different parts of the country.

Of the 13
saw-palmetto brands tested for this report, we found that only 8 had the
right amount of the right stuff: The number of pills recommended on the
label did supply the desirable amount of berry extract, at prices ranging
from 44 cents to $1.44 a day. The other 5 brands fell short--often woefully
short, with the recommended pills supplying as little as 1 percent of
the desirable daily dosage (see What
the brands contain).

A pressing
problem

Located at
the base of the bladder, the prostate gland produces most of the fluid
in semen. Normally it's the size of a walnut. But over the years the cumulative
effect of the male hormone dihydrotestosterone (DHT) tends to make the
gland grow larger, by an average of 175 percent. As a result, it may start
to constrict the urethra (the tube that runs through the prostate and
carries urine out of the bladder), thereby interrupting normal urine flow.
In addition, muscle tone in or near the prostate tends to gradually increase
with age; that may eventually trigger recurrent muscle spasms that can
restrict the flow of urine. Both processes prevent complete emptying of
the bladder, resulting in a frequent, urgent need to urinate, often in
the middle of the night; spasms can interrupt the stream as well and sometimes
even stop it entirely.

BPH is generally
not a dangerous condition, but individuals bothered by any of those urinary
symptoms should see a doctor to rule out other diseases such as diabetes,
prostate or bladder infection, neurologic disorders, and cancer. If the
problem is BPH, a doctor can help you decide whether to treat it, and
if so, how.

BPH sometimes
improves spontaneously. The decision on what to do--watchful waiting or
treatment with saw palmetto, prescription medicine, or surgery--should
be driven by how bothersome your symptoms are. If the problem is mild,
watchful waiting may be all you need. That means seeing the doctor for
regular checkups and taking such steps as limiting evening intake of fluids,
particularly alcohol and coffee. Make sure to ask the doctor whether any
drugs you're taking--especially diuretics (water pills), antihistamines,
decongestants, antidepressants, and tranquilizers--might be aggravating
the problem.

However,
men whose sleep is continually disrupted by the frequent need to urinate
at night or whose lifestyle is circumscribed by having to stay within
dashing distance of a bathroom should consider treatment.

Herbal therapy

Researchers
aren't sure how saw palmetto works, although they have isolated numerous
substances, including certain fatty acids, that appear to be active. Some
lab studies suggest that the herbal remedy may have a weak antihormonal
effect (too weak to blunt the sex drive or cause feminizing changes);
others suggest that it may inhibit the proliferation of prostate cells
or help fight inflammation. One recent study did find that saw palmetto
decreased prostate size, although several other studies found no such
effect.

Most clinical
trials have tested saw palmetto against a placebo, not against a prescription
drug. In 1998 the Journal of the American Medical Association published
a review of 18 such clinical trials. The review, by researchers at the
Minneapolis VA Medical Center and other institutions, concluded that the
evidence points in saw palmetto's favor. Overall, about three-quarters
of BPH patients taking the herb reported an improvement in symptoms, compared
with about half of those on placebo. (Such a strong placebo response is
not uncommon in clinical trials, particularly if the disorder waxes and
wanes.) Moreover, saw palmetto appears to relieve several types of symptoms:
It boosted the strength of the urine stream, allowed more-complete emptying
of the bladder, and reduced the number of nighttime trips to the bathroom.
Those benefits added up to a 37 percent improvement in urinary symptoms.

In the world
of herbal medicines, where research is usually scanty, that evidence is
rather impressive. But it still falls short of what's usually required
for drug approval by the Food and Drug Administration (FDA). The clinical
trials have typically lasted only six months or less, while prescription
prostate drugs have proved their safety and efficacy in studies lasting
up to six years. The American Urological Association (AUA), which represents
urologists, says it's keeping an open mind while awaiting the outcome
of longer clinical trials, including a one-year placebo-controlled study
of saw palmetto funded by the National Institutes of Health.

"What worries
me is that we don't know about drug interactions," says H. Logan Holtgrewe,
M.D., chairman of the AUA's health-care policy committee. In contrast,
he says, "we have two families of medications that have been shown efficacious
based on good evidence from prospective, randomized, blinded clinical
trials."

As good as
a drug?

Saw palmetto
costs about $15 to $45 per month (usually not covered by insurance), compared
with about $85 for finasteride (Proscar) and $45 to $75 for an
alpha-blocker such as doxazosin (Cardura), terazosin (Hytrin),
or tamsulosin (Flomax). A recent survey found that some 85 percent
of urologists would treat moderate prostate problems with one or more
of those prescription drugs, whose combined sales approached $1 billion
last year.

Finasteride
shrinks the prostate by decreasing production of DHT. It works best in
the minority of patients with BPH whose gland is greatly enlarged. Few
studies have compared finasteride with saw palmetto. But in one six-month
trial of more than 1,000 BPH patients, the drug increased urinary flow
by 30 percent, while the herbal remedy boosted flow by a comparable 25
percent. What's more, the herbal did not cause the most troublesome side
effect of finasteride: erectile dysfunction in about 9 percent of men.
And unlike the drug, saw palmetto doesn't interfere with the standard
prostate specific antigen (PSA) cancer-screening test. However, the study
was too short to draw definite conclusions, since saw palmetto's effects
typically kick in within one to two months, whereas finasteride's sometimes
take more than six months.

"I think
most physicians feel that finasteride's main role in the treatment of
BPH is the long-term prevention of complications, such as complete bladder
blockage, and of progression to surgery," says Michael Barry, MD, chief
of the general medicine unit at Massachusetts General Hospital in Boston.
"There's no evidence that saw palmetto conveys that benefit."

Something
faster

The other
first-line drug treatment for BPH symptoms is an alpha-blocker. Rather
than shrinking the prostate, alpha-blockers ease muscle spasms in the
prostate and the bladder neck, thus easing constriction of the urethra.

In clinical
trials, alpha-blockers have reduced symptoms faster and better than finasteride,
although we could find no published data on whether they prevent long-term
complications. One published study found that saw palmetto relieved symptoms
almost as effectively as an alpha-blocker, but the USP's reviewers concluded
that the study was too loosely designed to draw reliable conclusions.

In the recent
Consumer Reports survey, readers with benign prostate problems
rated prescription medications, presumably including alpha-blockers, more
effective than saw palmetto. As our tests suggest, however, some of those
readers probably took pills that supplied relatively small doses of saw
palmetto.

Overall,
a few points do seem clear. Alpha-blockers work faster than saw palmetto,
starting to relieve symptoms in as little as one week. But alpha-blockers,
particularly doxazosin and terazosin, can cause reduced blood pressure,
necessitating careful monitoring with frequent blood-pressure checks.

While some
doctors are starting to recommend saw palmetto for patients with mild
symptoms--or at least not flinch when patients want to try it--others
are unenthusiastic. Claus Roehrborn, M.D., an associate professor of urology
at the University of Texas Southwestern Medical Center in Dallas, considers
saw palmetto "nothing but junk food." That's because the FDA regulates
herbals as foods, not drugs.

Physicians
might be more inclined to recommend the herbal medicine if they could
be assured that the pills contain the known or probable active ingredients
in the amount shown to work in well-designed studies and that the labeled
dosages were accurate and appropriate. But as our tests of saw palmetto
show, some herbal products may still contain far too little of the apparently
active ingredient.

Recommendations

Although the
long-term safety and efficacy of saw palmetto remain unclear, Consumers
Union's medical consultants say there's enough evidence to conclude that
supplements containing at least 320 milligrams per day of saw-palmetto
extract, the amount that worked in clinical trials, might be worth trying
for some men with mild symptoms; they should discuss that option with
their doctor. If symptoms don't improve after two months of taking the
remedy, it's probably time to try another approach.

As our tests
indicate, makers of some saw-palmetto products need to do a better job
of producing standardized, properly labeled products. And the FDA should
act on its promise to define good manufacturing practices for nutritional
supplements.

Men with
troublesome BPH symptoms that don't respond to evening fluid restriction,
drug-regimen changes, and possibly saw palmetto should turn to prescription
prostate medication. Because alpha-blockers work so rapidly, they're usually
worth trying before finasteride, especially for men with intermittent
urinary flow and no more than moderate prostate enlargement. If alpha-blockers
don't work, doctors can prescribe finasteride for men with a very large
prostate. If all else fails, paring down the prostate via surgery or one
of several other invasive techniques can be considered. The latest and
best study suggests that those methods do not increase the risks of incontinence
or impotence, although some may cause infertility.